Two manufacturers reported on recent results in acute kidney injury (AKI) studies.
Biopharmaceutical company AM-Pharma, based in Bunnik, the Netherlands, announced that its phase II STOP-AKI study demonstrated a noteworthy reduction in mortality in a 28-day period. The company is focused on the development of recombinant human alkaline phosphatase (recAP) for the treatment of AKI, ulcerative colitis, and hypophosphatasia. Pfizer acquired a minority interest in AM-Pharma in May 2015 and may acquire the rest of the company through an option.
The 301-patient study compared a treatment group of sepsis patients with AKI with a similar group receiving placebo. Adding recAP to standard of care did not have an effect during week 1 of the study, which was the study’s primary endpoint. However, recAP demonstrated a significant and dose-dependent relative reduction in mortality of more than 40% in the treatment group compared with the placebo group. The researchers also reported a significant, progressive, and sustained improvement in renal function over the entire 28-day study period.
Principal investigator Peter Pikkers, chair of experimental intensive care medicine at Radboud University Medical Center, Nijmegen, the Netherlands, presented the data at the International Conference on Advances in Critical Care Nephrology in San Diego in March 2018. He said that the significant improvement demonstrated in survival and kidney function “are very encouraging and strongly support further development of recAP,” BioWorld.com reported.
At the same conference, La Jolla Pharmaceutical presented its work, “Outcomes in Patients with Acute Kidney Injury Receiving Angiotensin II for Vasodilatory Shock.”
A La Jolla online Power Point presentation refers to Giapreza as a novel vasopressor that is the “first and only synthetic human angiotensin II.”
Researchers analyzed the data from 105 AKI patients requiring renal replacement therapy at the initiation of the drug study. Survival through day 28 was 53% for the Giapreza group compared with 30% for the placebo group (p = 0.012). By the end of the first week, 38% of patients treated with Giapreza discontinued renal replacement therapy compared with 15% of patients treated with placebo (p = 0.007). The study results were published online in Critical Care Medicine.
“Acute kidney injury requiring dialysis associated with distributive shock…represents a significant medical risk for patients and a significant financial burden to the healthcare system,” said study presenter James Tumlin, MD, professor of medicine at the University of Tennessee at Chattanooga and director of the NephroNet Clinical Trials Consortium. “These analyses of the effect of angiotensin II on AKI patients requiring dialysis in the ATHOS-3 Study demonstrated angiotensin II is a promising therapy to address this unmet need.”